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What is a combination product?

Understanding Combination Products: A Blend of Medications and Devices

In the ever-evolving landscape of healthcare, innovation knows no bounds. As medical science continues to advance, so does our ability to create groundbreaking products that bridge the gap between different realms of medicine. One such innovation that has gained significant prominence in recent years is the combination product. Combining the features and functionalities of drugs, devices, and biological products, combination products have revolutionized the way we approach diagnosis, treatment, and patient care. In this article, we delve into the concept of combination products, exploring their definition, types, and some real-world examples.

Defining Combination Products

The U.S. Food and Drug Administration (FDA), a regulatory authority at the forefront of healthcare in the United States, defines a combination product as "a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product."

To provide further clarity, the FDA has delineated four key categories under which a product can be classified as a combination product:

1. Single-Entity Combination Product

This type of combination product is comprised of two or more regulated components, such as a drug/device, biologic/device, drug/biologic, or drug/device/biologic. These components are physically, chemically, or otherwise combined or mixed to create a single entity. Essentially, they become inseparable, forming a unified product. An example of this is a monoclonal antibody combined with a therapeutic drug.

2. Co-Packaged Combination Product

Co-packaged combination products involve two or more separate products that are packaged together as a single unit. These packages contain combinations of drug and device products, device and biological products, or biological and drug products. For instance, a drug or vaccine vial packaged with a delivery device falls into this category.

3. Cross-Labeled Combination Product

In this category, a drug, device, or biological product is packaged separately but is intended for use only with an approved individually specified drug, device, or biological product. Both products are required to achieve the intended use, indication, or effect. Upon approval, the labeling of the approved product may need to be changed to reflect the new combination. An example is a photosensitizing drug and an activating laser/light source.

4. Another Type of Cross-Labeled Combination Product

Similar to the previous category, this type of combination product involves investigational products packaged separately but intended for use only with another individually specified investigational drug, device, or biological product. Both are needed to achieve the intended use, indication, or effect.

Real-World Examples

To better grasp the significance of combination products, let's explore some real-world examples that illustrate the various categories:

Single-Entity Combination Products

  1. Drug-Eluting Stent: A medical device used to open blocked arteries that is coated with a drug to prevent restenosis (re-narrowing of the artery).

  2. Transdermal Patch: A patch applied to the skin that delivers a drug over time, providing a consistent dosage.

  3. Prefilled Drug Delivery Systems: Devices like syringes and insulin injector pens preloaded with medication for easy administration.

Co-Packaged Combination Products

  1. First-Aid Kits: These kits contain a combination of devices like bandages and gauze alongside drugs like antibiotic ointments and pain relievers.

  2. Surgical Trays: Surgical trays often include an array of surgical instruments, drapes, and even anesthetic or antimicrobial swabs.

Cross-Labeled Combination Products

  1. Photosensitizing Drug and Laser/Light Source: Used in certain medical procedures, these products are provided separately but are explicitly labeled for use together to achieve the desired therapeutic effect.


Combination products represent a pivotal development in the healthcare industry, seamlessly integrating drugs, devices, and biological products to provide more effective and innovative solutions for patients. These multifaceted products offer new avenues for treatment, diagnosis, and care, driving the healthcare industry forward in its mission to improve patient outcomes and quality of life. As technology continues to advance and our understanding of medicine deepens, the realm of combination products is poised for further growth and innovation, promising a brighter and healthier future for all.

Contact BioBoston Consulting today or visit our website to learn more about how we can support your organization.

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